Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients

January 24, 2024 updated by: PulseMedica

Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking

Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Edmonton, Canada
        • Alberta Retina Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 18 and 70 years of age
  • Male or female
  • Diagnosed diabetic retinopathy
  • Two eyes with clear ocular media

Exclusion Criteria:

  • Patients younger than 18 years and over 70 years of age
  • Patients without diabetic retinopathy
  • Opacification of cornea, lens, or vitreous

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retinal Imaging using the OSNAT800 IO device
Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment.
Device: OSNAT 800 IO
Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful performance of the real-time eye tracking function by post-image processing
Time Frame: Through study completion, an average of 6 months
Successful acquisition of retinal images
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device usability as assessed by a survey
Time Frame: Through study completion, an average of 6 months
Qualitative assessment of user feedback
Through study completion, an average of 6 months
Image Quality as assessed by user assessment of image quality parameters
Time Frame: Through study completion, an average of 6 months
Qualitative assessment of image at time of acquisition
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PulseMedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Actual)

March 21, 2023

Study Completion (Actual)

March 21, 2023

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSNATFIHIO001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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